DecaMed powder for solution for oral administration 25mg in bags No. 10

Name:
Decamed
Description:
Powder of white or almost white color with a smell of pineapple. Soft lumps are allowed. The main active ingredient Dexketoprofen Release form Powder for solution for oral administration 3.0 g of powder in a bag of combined material (paper, polyethylene, aluminum foil, polyethylene). Five or ten packs along with instructions for use in a pack of cardboard. Dosage 25 mg Pharmacological action Dexketoprofen trometamol belongs to the group of non-steroidal anti-inflammatory drugs, has an analgesic, anti-inflammatory, antipyretic effect. The analgesic effect occurs 30 minutes after ingestion. The duration of action is 4-6 hours. Indications for use Short-term symptomatic treatment of mild to moderate pain, such as acute muscle and bone pain, painful menstruation and toothache. Dosage and administrationAdults: The recommended dose, depending on the nature and severity of pain, is 25 mg with an interval of 8 hours. The total daily dose should not exceed 75 mg. DecaMed is intended for short-term use only and treatment should be limited to the duration of the symptoms. Dissolve the entire contents of the sachet in a glass of water. The solution should be taken immediately after preparation. Reception with food slows down the absorption of the drug; therefore, in case of acute pain, it is recommended to take the drug at least 15 minutes before meals. The occurrence of adverse reactions can be minimized by using the lowest effective dose for the shortest period of time necessary to improve the condition. Special groups of patients Elderly patients: Elderly patients are recommended to start treatment with a low dose (total daily dose of 50 mg). Only in case of good tolerability in elderly patients, the initial dose can be further increased to the dose recommended for normal patients. Due to the risk of side effects of a certain profile, elderly patients should be under special medical supervision. In case of impaired liver function: For patients with mild to moderate liver disease, treatment should be started at a low dose (total daily dose of 50 mg) and under close medical supervision. The drug is contraindicated in patients with severe liver dysfunction. Impaired renal function: For patients with mild renal impairment (creatinine clearance 59-89 ml / min), the initial dose should be reduced to 50 mg per day. In patients with moderate to severe renal dysfunction (creatinine clearance <59 ml / min), the drug is contraindicated. Pediatric age: Safety and efficacy in children and adolescents have not been established. Use in children and adolescents under 18 years of age is contraindicated. Use during pregnancy and lactation Prescribing the drug in the third trimester of pregnancy and lactation is contraindicated. Pregnancy Suppression of prostaglandin synthesis may adversely affect pregnancy and/or fetal and fetal development. According to the results of epidemiological studies, in early pregnancy, the use of drugs that suppress the synthesis of prostaglandins increases the risk of miscarriage, the occurrence of heart disease in the fetus and non-closure of the anterior abdominal wall. Thus, the absolute risk of developing anomalies of the cardiovascular system increased from < 1% to approximately 1.5%. It is believed that the risk of these phenomena increases with an increase in the dose of the drug and the duration of therapy. In animals, the use of a prostaglandin synthesis inhibitor contributed to an increased risk of pre- and post-implantation losses and an increase in embryo-fetal mortality. In addition, in animals treated with inhibitors of prostaglandin synthesis during organogenesis, the incidence of fetal malformations, including anomalies of the cardiovascular system, increased. However, studies of dexketoprofen trometamol in animals have not revealed signs of toxicity to the reproductive organs. The appointment of dexketoprofen trometamol in the first and second trimester of pregnancy is possible only when there is an urgent need for it. When prescribing dexketoprofen trometamol to women planning a pregnancy, or in the first and second trimester of pregnancy, the lowest possible dose with the shortest duration of treatment should be chosen. Against the background of the use of prostaglandin synthesis inhibitors in the third trimester of pregnancy in the fetus, the following deviations are possible: manifestations of cardiopulmonary toxicity (for example, premature closure of the arterial duct and hypertension in the pulmonary artery system); renal dysfunction, which may progress to renal failure with oligohydramnios. In the mother at the end of pregnancy and in the newborn, the following phenomena are possible: - an increase in bleeding time - the effect of inhibiting platelet aggregation, which is possible even when using the drug in very low doses, suppression of the contractile activity of the uterus, leading to a delay or delay in labor. Fertility The use of the drug may have a negative effect on the reproductive function in women; therefore, the drug is not recommended for women planning pregnancy. In women who have problems conceiving or who are being tested for infertility, discontinuation of dexketoprofen trometamol should be considered. Lactation There is no information on the transition of dexketoprofen into breast milk. The appointment of the drug during breastfeeding is contraindicated. PrecautionsDecaMed contains aspartame, a source of phenylalanine. May be harmful to people with phenylketonuria. The safety of use in children and adolescents has not been confirmed. Use with caution in patients with a history of allergic reactions. Avoid using the drug in combination with other NSAIDs, including selective cyclooxygenase-2 inhibitors. Each sachet contains 2.807 g of sucrose, which must be taken into account for daily use in case of a low sugar diet or diabetes. Side effects can be minimized by using the lowest effective dose for the shortest time necessary to improve the condition. Gastrointestinal disorders Gastrointestinal bleeding, ulcer and perforation. Gastrointestinal bleeding, ulcer formation or perforation, in some cases fatal, have been reported for all NSAIDs at different stages of treatment, regardless of the presence of precursor symptoms or a history of serious gastrointestinal pathology. With the development of gastrointestinal bleeding against the background of the use of dexketoprofen trometamol, the drug should be discontinued. The risk of gastrointestinal bleeding, ulcer formation or perforation increases with increasing dose of NSAIDs in patients with a history of ulcer, especially complicated by bleeding or perforation, as well as in elderly patients. Elderly patients: Elderly patients have an increased incidence of side effects of NSAIDs, especially gastrointestinal bleeding and ulcer perforation, which can be life-threatening. Treatment of these patients should begin with the lowest possible dose. Before starting treatment with dexketoprofen trometamol and in the presence of a history of esophagitis, gastritis and / or peptic ulcer, as in the case of other NSAIDs, it should be ensured that these diseases are in remission. In patients with symptoms of gastrointestinal pathology and with a history of gastrointestinal diseases, it is necessary to monitor for disorders of the digestive tract, especially for gastrointestinal bleeding. NSAIDs should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), since there is a risk of exacerbation of these diseases. For these patients, as well as patients who require concomitant treatment with low-dose aspirin or other drugs that increase the risk of gastrointestinal disorders, combination therapy with protective drugs, such as misoprostol or inhibitors, should be considered. proton pumps. Patients, especially the elderly, who have had a history of gastrointestinal side effects should report - especially at the initial stages of treatment - all unusual symptoms associated with the digestive system (in particular gastrointestinal bleeding). Caution should be exercised when prescribing the drug to patients who are simultaneously taking drugs that may increase the risk of ulcers or bleeding: oral corticosteroids, anticoagulants (for example, warfarin), selective serotonin reuptake inhibitors or antiplatelet agents, such as aspirin. Renal disorders In patients with impaired renal function, the drug should be administered with caution, since the use of NSAIDs may worsen kidney function, fluid retention in the body and edema. In view of the increased risk of nephrotoxicity, the drug should be used with caution in the treatment of diuretics, as well as in those patients who may develop hypovolemia. During treatment, the body must receive enough fluid to avoid dehydration, which can lead to an increase in the toxic effect of the drug. Like all NSAIDs, the drug is able to increase the concentration of urea nitrogen and creatinine in the blood plasma. Like other inhibitors of prostaglandin synthesis, its use may be accompanied by side effects from the kidneys, leading to glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome and acute renal failure. Older people are more susceptible to impaired kidney function. Liver disorders Patients with impaired hepatic function should use the drug with caution. Similar to other NSAIDs, the drug can cause a temporary and slight increase in some hepatic parameters, as well as a pronounced increase in the activity of AST and ALT. With a corresponding increase in these indicators, therapy should be discontinued. The elderly are more susceptible to liver dysfunction. Cardiovascular and cerebrovascular disorders Patients with a history of hypertension and/or mild to moderate heart failure require appropriate monitoring and advice. Particular care must be taken in the treatment of patients with a history of heart disease, in particular, with previous episodes of heart failure, since NSAID therapy can increase the risk of developing heart failure; cases of fluid retention and edema associated with NSAIDs have been described. According to the results of clinical studies and epidemiological data, the use of some NSAIDs, especially at high doses and for a long time, may be accompanied by a slight increase in the risk of arterial thrombosis (for example, myocardial infarction or stroke). There are not enough data to exclude such a risk when using dexketoprofen trometamol. Therefore, in cases of uncontrolled arterial hypertension, congestive heart failure, coronary heart disease, diseases of the peripheral arteries and / or cerebral vessels, dexketoprofen trometamol should be prescribed only after a thorough assessment of the patient's condition. The same questions should be addressed before initiating long-term treatment in patients with cardiovascular risk factors (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking). Non-selective NSAIDs can reduce platelet aggregation and increase bleeding time by inhibiting prostaglandin synthesis. Therefore, the appointment of dexketoprofen trometamol is not recommended for patients receiving drugs that affect hemostasis, such as warfarin or other coumarins or heparins. Elderly patients are more susceptible to dysfunction of the cardiovascular system. Skin reactions Very rare cases of severe skin reactions, sometimes fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis of NSAIDs, have been described in association with the use of NSAIDs. Apparently, the highest risk of developing toxic skin reactions in the initial period of therapy, since in most cases skin reactions develop during the first month of treatment. At the first sign of skin rash, mucosal lesions or other symptoms of hypersensitivity, the drug should be discontinued. Other information Special care is required when prescribing the drug to patients with: - congenital disorders of porphyrin metabolism (for example, with acute intermittent porphyria); - dehydration; - immediately after major surgery. If the doctor considers that long-term use of dexketoprofen is necessary, liver and kidney function should be monitored regularly. In very rare cases, severe acute hypersensitivity reactions (eg, anaphylactic shock) have been observed. At the first sign of a severe hypersensitivity reaction, stop taking the drug and consult a doctor to take the necessary therapeutic measures, depending on the symptoms. Patients suffering from asthma in combination with chronic rhinitis, chronic sinusitis and/or nasal polyps are at a higher risk of allergy to acetylsalicylic acid and/or NSAIDs than the general population. Administration of this medicinal product may cause asthma attacks or bronchospasm, especially in patients who are allergic to acetylsalicylic acid or NSAIDs. In special cases, it is possible to develop severe infectious complications from the skin and soft tissues against the background of chicken pox. To date, it is impossible to completely exclude the possibility of an association between NSAIDs and the development of such infectious complications. Therefore, with chickenpox, the drug should be avoided. The drug should be used with caution in hematopoietic disorders, systemic lupus erythematosus or mixed connective tissue disease. Like other NSAIDs, dexketoprofen is able to mask the symptoms of infectious diseases. This medicinal product contains sucrose. In this regard, it is contraindicated in patients with hereditary diseases such as fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency. Children Safety and efficacy in children have not been established; therefore, the drug should not be used in children and adolescents. Effects on the ability to drive or use machines Dexketoprofen can cause side effects such as dizziness, visual disturbances or drowsiness. In such cases, there may be a deterioration in the ability to respond quickly, orientate in a traffic situation and the ability to control mechanisms. Interactions with other drugs The following are general interactions for all NSAIDs: The following drugs are not recommended for use with NSAIDs: - Other NSAIDs, including cyclooxygenase-2 inhibitors and salicylates at high doses (> 3 g / day): when several NSAIDs are used together, the risk increases the development of ulcers and gastrointestinal bleeding due to the mutually reinforcing action of these drugs. – Anticoagulants: NSAIDs enhance the effect of anticoagulants, such as warfarin, due to the high degree of binding of dexketoprofen to plasma proteins, as well as suppression of platelet function and damage to the gastric and duodenal mucosa. If co-administration is necessary, it should be under close medical supervision and laboratory monitoring. – Heparins: increased risk of bleeding (due to suppression of platelet function and damage to the gastric and duodenal mucosa). If co-administration is necessary, it should be under close medical supervision and laboratory monitoring. – Corticosteroids: increased risk of ulcers and gastrointestinal bleeding. – Lithium (described for several NSAIDs): NSAIDs increase the concentration of lithium in the blood, which can lead to intoxication (decreased excretion of lithium by the kidneys). Therefore, at the beginning of the use of dexketoprofen, when adjusting the dose and canceling the drug, it is necessary to control the concentration of lithium. – Methotrexate in high doses (15 mg per week or higher): due to the decrease in renal clearance of methotrexate against the background of the use of anti-inflammatory drugs in general, its harmful effects on the blood system are enhanced. – Hydantoin derivatives and sulfonamides: it is possible to increase the toxic properties of these substances. The following drugs are recommended to be used with caution in combination with the drug: – Dexketoprofen weakens the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (for example, those who are dehydrated or elderly patients with impaired renal function), the use of drugs that suppress cyclooxygenase, together with ACE inhibitors, angiotensin II receptor antagonists, or aminoglycoside antibiotics, may aggravate the condition, which, as the rule is reversible. When prescribing dexketoprofen concomitantly with a diuretic, it is imperative to ensure that the patient is receiving adequate fluids, as well as to monitor renal function at the beginning of treatment and, periodically, thereafter. Co-administration of dexketoprofen trometamol and potassium-sparing diuretics may lead to hyperkalemia. It is necessary to regularly monitor the concentration of potassium in the blood. – Methotrexate at low doses, less than 15 mg per week: due to a decrease in the renal clearance of methotrexate against the background of the use of anti-inflammatory drugs, its toxic effect on the blood system as a whole is enhanced. In the first weeks of joint use, a weekly blood test should be done. Even with a slight impairment of kidney function, as well as in elderly patients, treatment should be carried out under the strict supervision of a physician. – Pentoxifylline: increased risk of bleeding. It is necessary to strengthen control and more often check such an indicator as bleeding time. – Zidovudine: there is a risk of increased toxic effects on erythrocytes due to the effect on reticulocytes, which after the first week of NSAID use leads to severe anemia. Within one to two weeks after the start of the use of NSAIDs, a detailed blood test should be done and the content of reticulocytes should be checked. – Sulfonylureas: NSAIDs can enhance the hypoglycemic effect of sulfonylurea by replacing them in compounds with plasma proteins. The following combinations should be taken into account: – Beta-blockers: NSAIDs can reduce their hypotensive effect by inhibiting prostaglandin synthesis. – Cyclosporine and tacrolimus: possible increased nephrotoxicity due to the effect of NSAIDs on renal prostaglandins. In combination therapy, renal function should be monitored. – Thrombolytics: increased risk of bleeding. – Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. – Probenecid: an increase in the concentration of dexketoprofen in plasma is possible, which is probably due to the suppression of tubular secretion and conjugation of the drug with glucuronic acid and requires dose adjustment of dexketoprofen. – Cardiac glycosides: NSAIDs are able to increase the concentration of glycosides in plasma. – Mifepristone: There is a theoretical risk of changing the effectiveness of mifepristone under the influence of prostaglandin synthetase inhibitors. Limited evidence suggests that co-administration of NSAIDs on the same day with prostaglandin does not adversely affect the effects of mifepristone or prostaglandin on cervical maturation or uterine contractility, and does not reduce the clinical efficacy of medical abortion agents. – Antibiotics of the quinolone series: Animal studies have shown that the use of high doses of quinolone derivatives in combination with NSAIDs increases the risk of seizures. Contraindications – increased individual sensitivity to the components of the drug or any other NSAID; – fructose intolerance, glucose / galactose malabsorption or sucrose-isomaltase deficiency (due to the presence of sugar in the composition); – the development of asthma attacks, bronchospasm, acute rhinitis or the development of nasal polyps, the appearance of urticaria or angioedema when using substances of a similar effect (for example, acetylsalicylic acid and other NSAIDs); – development of photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates; – a history of gastrointestinal bleeding or perforation associated with previous NSAID therapy; – active peptic ulcer / gastrointestinal bleeding, or a history of gastrointestinal bleeding, ulceration or perforation; – chronic dyspepsia; – gastrointestinal bleeding, other bleeding in the active phase or increased bleeding; – Crohn’s disease or ulcerative colitis; – severe heart failure; – impaired renal function of moderate or severe degree (creatinine clearance <59 ml / min); - severe liver dysfunction (10-15 points on the Child-Pugh scale); hemorrhagic diathesis and other blood clotting disorders; - severe dehydration (as a result of vomiting, diarrhea or insufficient fluid intake); - third trimester of pregnancy and lactation; - children under 18 years of age (due to the lack of data on efficacy and safety). Composition 1 package contains: active ingredient: dexketoprofen, in the form of dexketoprofen trometamol - 25.0 mg. excipients: sodium citrate, flavor "Pineapple", aspartame, sugar (Extra). Overdose Symptoms of overdose are unknown. Similar drugs cause gastrointestinal disorders (vomiting, anorexia, abdominal pain) and the nervous system (drowsiness, dizziness, disorientation, headaches). In case of accidental overdose, symptomatic treatment should be started immediately in accordance with the patient's condition. When taking more than 5 mg / kg, an adult or child should give activated charcoal orally within an hour. Dexketoprofen trometamol is removed from the body by dialysis. Side effects Side effects can be reduced by using the smallest effective dose for the minimum time necessary to improve the condition. The drug is intended for short-term use only; treatment should be limited to the period of symptoms. The table indicates and distributed by organs and organ systems and the frequency of occurrence of adverse events, the relationship of which with dexketoprofen trometamol, according to clinical trials (dosage form - tablets), is recognized as at least possible. Since the maximum plasma concentration of dexketoprofen achieved with the pharmaceutical form of powder for oral solution is higher than for tablets, a potential increase in the risk of adverse reactions cannot be ruled out. The frequency categories used in this section are: very common (>1/10), common (>1/100 but <1/10), uncommon (>1/1000 but <1/100), rare (>1/100). 10,000 but <1/1000), very rare (<1/10,000), frequency unknown (cannot be estimated from available data). Organs and organ systems Common (>1/100-<1/10) Uncommon (>1/1000-<1/100) Rare (>1/10000-<1/1000) Very rare/single reports (< 1/10,000) Blood and lymphatic system disorders Neutropenia, thrombocytopenia Immune system disorders Laryngeal edema Anaphylactic reactions, including anaphylactic shock Nutritional and metabolic disorders Anorexia Psychiatric disorders Insomnia, anxiety Nervous system disorders Headaches, dizziness , drowsiness Paresthesia, fainting Visual disturbances Blurred vision Ear disturbances Dizziness Ringing in the ears Cardiac disorders Heart palpitations Tachycardia Vascular disorders Hot flushes Hypertension Arterial hypotension Respiratory, thoracic and mediastinal disorders Bradypnea Bronchospasm, dyspnea gastrointestinal tract Nausea and / or vomiting, stomach pain, diarrhea, dyspepsia. Gastritis, constipation, dry mouth, flatulence Peptic ulcer, bleeding or perforation Pancreatitis Liver and biliary tract disorders Liver cell damage Skin and subcutaneous tissue disorders Rash Urticaria, acne, increased sweating Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), angioedema, facial edema, photosensitivity reaction, pruritus Musculoskeletal and connective tissue disorders Back pain Kidney and urinary tract disorders Polyuria, acute renal failure Nephritis or nephrotic syndrome Reproductive system and mammary gland disorders Menstrual irregularities, prostatic dysfunction Systemic and injection site reactions Fatigue, pain, asthenia, muscle stiffness, feeling unwell Peripheral edema Additional examination methods Abnormal liver tests Reported possible side effects Reported Information about possible side effects after the registration of the medicinal product plays an important role. This allows continued monitoring of the benefit/risk ratio of the medicinal product. Health care workers are required to report any possible adverse events through the national reporting system. The most common side effects are from the gastrointestinal tract. Thus, it is possible to develop peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, especially in elderly patients. According to available data, against the background of the use of the drug, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease may occur. Rarely observed gastritis. Edema, arterial hypertension and heart failure have also been reported during NSAID treatment. According to clinical trials and epidemiological data, the use of some NSAIDs, especially at high doses and for a long time, may be accompanied by a slight increase in the risk of developing pathologies caused by arterial thrombosis (for example, myocardial infarction or stroke). As with other NSAIDs, the following side effects are possible: aseptic meningitis, which mainly occurs in patients with systemic lupus erythematosus or mixed collagenoses, and reactions from the blood (purpura, hypoplastic and hemolytic anemia, rarely - agranulocytosis and bone marrow hypoplasia) . Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children! Shelf life 18 months. Do not use after the expiration date indicated on the package. Buy DecaMed powder for oral solution 25mg in bags No. 10 inside 25mg in packages No. 10